Job Details

  • Title: Regulatory Affairs Project Leader
  • Code: RCI-6443
  • Location: Princeton New Jersey (NJ) 08540
  • Posted Date: 11/18/2020
  • Duration: 6 Months
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  Job Description

Top 3 Skills

  • 510K submissions
  • IVD experience
  • Technical background
Education:

Bachelor's degree required, Masters degree preferred

Experience:

Minimum of 6 years experience

Skills:
  • Demonstrated experience clearing devices in US
Duties:
  • Demonstrated ability to work effectively in a team environment. Responsible for writing and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.
  • Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.
  • Prior regulatory experience with IVDs or medical devices is required.
  • Position is highly visible to internal stakeholders.
  • Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.
  • Communicates issues to management through project management tracking and issue briefings.
  • High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.
  • Experience with CLIA waived products is a plus.
  • Ability to communicate effectively in writing crisp briefings and issue analysis.
  • Responsible for effective communication of regulatory requirements to project teams and internal customers